A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)

Completed

• Conditions: Dyslipidemia; Hypercholesterolemia

• Registration Number: NCT01414192
• Lead Sponsor: Organon and Co

Brief Summary

This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-15
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2014-09-15
• Study Completion: 2014-09-15
• Results First Submitted: 2015-09-14
• Results First Submitted QC: 2015-12-02
• Results First Posted: 2016-01-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3215

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Cardiovascular (CV) Events	up to 48 months	Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months	Baseline and Month 12	LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months	up to 48 months	Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.
Percentage of Participants With at Least 1 Discontinuation of Study Drug	up to 48 months	The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.
Percentage of Participants With CV Risk Factors	At enrollment (baseline)	Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol \& substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.
Mortality Rate	up to 48 months	The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.